SUNMASTER
FDA 510(k) clearance K842276 · decided 1984-07-16
Clearance details
- K-number
- K842276
- Device name
- SUNMASTER
- Applicant
- Mt. Hood Mfr., Inc.
- Decision
- Substantially Equivalent
- Date received
- 1984-06-08
- Decision date
- 1984-07-16
- Days to decision
- 38 days
- Clearance type
- Traditional
- Product code
- IOB
- Device class
- 2
- Regulation number
- 890.5500
- Medical specialty
- Physical Medicine
- Advisory committee
- Physical Medicine
- Location
- Mchenry, IL, US
- Third-party review
- No
- Expedited review
- No
+ Add to Predicate Builder ◉ Watch Mt. Hood Mfr.
Need this as data, not a web page?
Query all 176,000+ clearances through the Atlas FDA API, or subscribe to weekly change alerts. Self-serve from $29/mo.
Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| DERMALIGHT PSORACOMB (K903660) | Solitec GmbH | 1991-07-17 |
| ULTRALITE PANELITE (K910091) | Ultralite | 1991-05-30 |
| UVA FLUORESCENT TANNING LAMPS (K813451) | North American Philips Corp. | 1982-01-28 |
| OSRAM UVA LAMP (K812853) | Osram GmbH | 1981-12-09 |
| SUNLAMP, FLOURESCENT DERMATRON F40-313 AND F20-313 (K760519) | Dermatron Corp. | 1976-09-03 |
Recalls involving this device
No recalls on record reference this clearance.